Cleared Traditional

K781343 - RESURFACE PROSHESIS (FDA 510(k) Clearance)

K781343 · Aesculap Instruments Corp. · Orthopedic device
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Sep 1978
Decision
54d
Days
-
Risk

K781343 is an FDA 510(k) clearance for the RESURFACE PROSHESIS.

Submitted by Aesculap Instruments Corp. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1978 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aesculap Instruments Corp. devices

Submission Details

510(k) Number K781343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1978
Decision Date September 27, 1978
Days to Decision 54 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 122d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -